Duns Number:086785110
Device Description: The VITEK® 2 ANC Identification Card is intended for use with the VITEK 2 Systems for ID o The VITEK® 2 ANC Identification Card is intended for use with the VITEK 2 Systems for ID of clinically important anaerobic bacteria and coryneform bacteria
Catalog Number
-
Brand Name
VITEK® 2 ANC
Version/Model Number
VITEK® 2 ANC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JSP
Product Code Name
KIT, ANAEROBIC IDENTIFICATION
Public Device Record Key
75822c7b-2350-45e9-9147-de9c211e3de5
Public Version Date
May 10, 2022
Public Version Number
2
DI Record Publish Date
June 02, 2020
Package DI Number
03573026144364
Quantity per Package
20
Contains DI Package
03573026529727
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |